The Nation; Weighing Hope Against Horror

By SHERYL GAY STOLBERG

Published: September 28, 1997

WASHINGTON—
NOW that thalidomide, the drug that was banned worldwide in the 1960's after it produced 10,000 babies with missing and stunted limbs, is headed for approval by the Food and Drug Administration, Randy Warren has a question: Are the benefits of the world's most notorious sedative worth the risk that just one more baby will be born like him?

Mr. Warren, 36, a Canadian whose mother took the drug when she was pregnant, was born with flipperlike feet where his kneecaps should be, four fingers on each hand and severely deformed ears. He had 24 operations by the time he turned 16; he remains wheelchair bound and unable to perform simple tasks like buttoning up his shirt.

''One baby born for 100 lives extended?'' he asked rhetorically last week, a few days after the F.D.A. announced that it intended to approve thalidomide for leprosy patients. ''If there is a number, I would like to know what it is. How are you going to measure that?''

No one has performed such a cold-hearted risk-benefit analysis, of course, and no one intends to, which is precisely Mr. Warren's point. Yet in the contentious debate over the return of thalidomide, which holds promise as a treatment for maladies as diverse as AIDS, lupus and cancer, there is one point upon which nearly everyone agrees: more deformed babies will be born if the drug comes to market.

''There will be some slip-ups,'' predicted Dr. Norman Fost, who directs the medical ethics program at the University of Wisconsin. ''There is no policy that will produce zero.'' But no one, he added, is willing to answer the most volatile question of all: How many thalidomide babies is too many?

In part, this is because Americans don't like to confront risk, be it the danger of contaminated hamburger meat or automobile air bags. Dr. John Graham, director of the Center for Risk Analysis at Harvard University, says an honest intellectual discussion of thalidomide should include some numbers crunching. But he doesn't expect it: ''We as a society do not want to face up to these numbers and their implications.''

The drug's maker, the Celgene Corporation of Warren, N.J., maintains that it can't crunch any numbers, because no one knows how many babies might be born and the potential uses of thalidomide will grow as scientists discover more diseases for which the drug is useful. Instead, the company has focused on designing a plan to prevent birth defects.

The plan, which has drawn accolades from all sides, including from Mr. Warren, includes a variety of provisions. Pharmacies would register before dispensing the drug, and there would be no automatic refills. Female patients would have to show proof of contraception and undergo regular pregnancy tests, and education for doctors and patients would be mandatory, which experts say is critical given that so many Americans are too young to remember the thalidomide scare.

Still, the company is not foolhardy. ''We have obtained product liability insurance,'' said Celgene's vice president for marketing, Bruce Williams, although he added that he does not believe more deformed babies are inevitable. ''If I believed that,'' he said, ''I would not be doing this.''

Because no drug is 100 percent safe, the F.D.A. always weighs risks and benefits. The difference with thalidomide, according to Dr. Janet Woodcock, who directs the agency's Center for Drug Evaluation and Research, is that the side effects don't injure the patient but another person, namely her child. Dr. Woodcock says the best the agency can do is to monitor thalidomide once it is on the market, and re-evaluate if too many accidents occur.

To Dr. Fost, that answer is not good enough. He would like the agency to confront the numbers question up front. ''If there are 10, 20, 50 or 100 or 200 of these kids five years from now, we will all look back and have heart-wrenching symposia and TV specials on whether the right precautions were taken,'' he said. ''So we should answer that question now.''